Supporting Transitions to Primary Care Among Under-resourced, Postpartum Women (STEP-UP)

NCT05852054 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2025-08-13

No results posted yet for this study

Summary

STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior gestational diabetes mellitus (GDM) and/or hypertensive disorders of pregnancy (HDP).

Conditions

  • Gestational Diabetes Mellitus
  • Hypertension in Pregnancy
  • Dysglycemia

Interventions

BEHAVIORAL

OB Provider Clinical Decision Support (CDS)

When an eligible patients' chart is opened by a provider, the provider will be alerted to counsel patients about future risk for T2D and hypertension and the need to establish a primary care medical home. The alert will include a 'referral' to primary care and a brief guide with 'key points for counseling'. For patients with prior GDM, this will also include an option to order guideline-recommended oral glucose tolerance test (OGTT) with a single click.

BEHAVIORAL

Patient Education (OB Visit)

A 1-page document will be printed or delivered electronically for eligible patients after every postpartum OB visit during the STEP-UP condition. The document will encourage patients to know the risk and will describe the importance of routine primary care and chronic disease evaluation and management. It will also provide tips for lowering risk through lifestyle changes. Patient materials will be delivered in English or Spanish based on the structured EHR variable for preferred language.

BEHAVIORAL

Text messaging

At 3 months postpartum, all eligible patients who have not scheduled a primary care visit will receive a motivational text to prompt scheduling; a second text will be sent for those who still have not made an appointment. Among those who schedule a visit, a reminder text will be sent before the visit. Texts will be in English or Spanish based on patients' preferred language field in the EHR and written at a \<5th grade reading level.

BEHAVIORAL

Patient Outreach

Patients who have not scheduled a primary care visit by 4 months postpartum will receive outreach from a trained coordinator who will assist with scheduling and help patients troubleshoot common barriers, such as concerns about transportation or cost.

BEHAVIORAL

Primary Care Provider Clinical Decision Support (CDS)

The CDS will notify the provider that the patient had a recent high-risk pregnancy and signal the need to counsel the individual about their future risk for T2D and/or hypertension and the need for ongoing care. A brief guide with 'key points for counseling' described in plain language will be provided. For patients with prior GDM, the CDS will also include an easy to access 'smartset' to order appropriate testing (A1c, FG, or OGTT) based on time since delivery and provider discussions with the patient.

BEHAVIORAL

Patient Education (Primary Care Visit)

A 1-page material will again be automatically printed or delivered electronically for eligible patients after their first primary care visit; it will replicate content from prior material provided after the OB visit.

Sponsors & Collaborators

Principal Investigators

  • Stacy Bailey, PhD MPH · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2025-09-01
Completion
2026-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05852054 on ClinicalTrials.gov